laronidase

Generic Name: laronidase (lah RAH nih daze)

Brand Names: Aldurazyme

What is laronidase?

Laronidase is used to treat some of the symptoms of a genetic condition called Hurler syndrome. Hurler syndrome is also called mucopolysaccharidosis (MYOO-koe-pol-ee-SAK-a-rye-DOE-sis).

Hurler syndrome is a metabolic disorder in which the body lacks the enzyme needed to break down certain sugars and proteins. These substances can build up in the body, causing enlarged organs, abnormal bone structure, changes in facial features, breathing problems, heart problems, vision or hearing loss, and changes in mental or physical abilities.

Laronidase may improve breathing and walking ability in people with this condition. However, this medication is not a cure for Hurler syndrome.

Laronidase may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about laronidase?

Laronidase may improve breathing and walking ability in people with Hurler syndrome. However, laronidase is not a cure for this condition. Some people receiving a laronidase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have a headache, skin rash or itching, warmth or tingly feeling, or trouble breathing when laronidase is injected.

Your name may need to be listed on a patient registry while you are using this medication. The purpose of this registry is to track the progression of this disorder and the effects that laronidase has on long-term treatment of Hurler syndrome.

What should I discuss with my healthcare provider before receiving laronidase?

You should not use this medication if you are allergic to laronidase.

Before using laronidase, tell your doctor if you are allergic to any drugs.

Your name may need to be listed on a patient registry while you are using this medication. The purpose of this registry is to track the progression of this disorder and the effects that laronidase has on long-term treatment of Hurler syndrome.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether laronidase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use laronidase?

Laronidase is given as an injection through a needle placed into a vein. You will most likely receive this injection in a clinic or hospital setting. Laronidase is usually given once per week.

The medicine must be given slowly through an IV infusion, and can take up to 4 hours to complete.

Your doctor may also prescribe other medications to help prevent an allergic reaction to laronidase. Take all of your medications as directed.

To be sure this medication is helping your condition and not causing harmful effects, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your laronidase injection.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

Symptoms of a laronidase overdose are not known.

What should I avoid while receiving laronidase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are receiving laronidase.

Laronidase side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Some people receiving a laronidase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have a headache, skin rash or itching, warmth or tingly feeling, or trouble breathing when laronidase is injected.

Less serious side effects may include:

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  runny or stuffy nose, sore throat, cough;

  
  


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  mild skin rash;

  
  


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  numbness or tingling; or

  
  


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  pain, redness, swelling, or other irritation where the medicine was injected.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Laronidase Dosing Information

Usual Adult Dose for Mucopolysaccharidosis Type I:

Recommended dose: 0.58 mg/kg of body weight administered once-weekly by intravenous infusion.

Pretreatment with antipyretics and/or antihistamines is recommended 60 minutes prior to the start of the infusion.

The total volume of the infusion is determined by the patient's body weight and should be delivered over approximately 3 to 4 hours. Patients with a body weight of 20 kg or less should receive a total volume of 100 mL. Patients with a body weight of greater than 20 kg should receive a total volume of 250 mL. The initial infusion rate of 10 mcg/kg/hr may be incrementally increased every 15 minutes during the first hour, as tolerated, until a maximum infusion rate of 200 mcg/kg/hr is reached. The maximum rate is then maintained for the remainder of the infusion (2 to 3 hours).

For Patients Weighing 20 kg or Less
Total Volume of laronidase Infusion = 100 mL
Start at 2 mL/hr x 15 minutes (10 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 4 mL/hr x 15 minutes (20 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 8 mL/hr x 15 minutes (50 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 16 mL/hr x 15 minutes (100 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 32 mL/hr x approximately 3 hours (200 mcg/kg/hr) for the remainder of the infusion.

For Patients Weighing Greater than 20 kg
Total Volume of laronidase Infusion = 250 mL
Start with 5 mL/hr x 15 minutes (10 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 10 mL/hr x 15 minutes (20 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 20 mL/hr x 15 minutes (50 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 40 mL/hr x 15 minutes (100 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 80 mL/hr x approximately 3 hours (200 mcg/kg/hr) for the remainder of the infusion.

Usual Pediatric Dose for Mucopolysaccharidosis Type I:

Greater then or equal to 5 years old:

Recommended dose: 0.58 mg/kg of body weight administered once-weekly by intravenous infusion.

Pretreatment with antipyretics and/or antihistamines is recommended 60 minutes prior to the start of the infusion.

The total volume of the infusion is determined by the patient's body weight and should be delivered over approximately 3 to 4 hours. Patients with a body weight of 20 kg or less should receive a total volume of 100 mL. Patients with a body weight of greater than 20 kg should receive a total volume of 250 mL. The initial infusion rate of 10 mcg/kg/hr may be incrementally increased every 15 minutes during the first hour, as tolerated, until a maximum infusion rate of 200 mcg/kg/hr is reached. The maximum rate is then maintained for the remainder of the infusion (2 to 3 hours).

For Patients Weighing 20 kg or Less
Total Volume of laronidase Infusion = 100 mL
Start at 2 mL/hr x 15 minutes (10 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 4 mL/hr x 15 minutes (20 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 8 mL/hr x 15 minutes (50 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 16 mL/hr x 15 minutes (100 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 32 mL/hr x approximately 3 hours (200 mcg/kg/hr) for the remainder of the infusion.

For Patients Weighing Greater than 20 kg
Total Volume of laronidase Infusion = 250 mL
Start with 5 mL/hr x 15 minutes (10 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 10 mL/hr x 15 minutes (20 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 20 mL/hr x 15 minutes (50 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 40 mL/hr x 15 minutes (100 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 80 mL/hr x approximately 3 hours (200 mcg/kg/hr) for the remainder of the infusion.

What other drugs will affect laronidase?

There may be other drugs that can interact with laronidase. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More laronidase resources

• Laronidase Side Effects (in more detail)
• Laronidase Dosage
• Laronidase Use in Pregnancy & Breastfeeding
• Laronidase Drug Interactions
• Laronidase Support Group
• 0 Reviews for Laronidase - Add your own review/rating

• laronidase Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Laronidase Professional Patient Advice (Wolters Kluwer)


• Laronidase MedFacts Consumer Leaflet (Wolters Kluwer)


• Laronidase Monograph (AHFS DI)


• Aldurazyme Prescribing Information (FDA)


• Aldurazyme Consumer Overview

Compare laronidase with other medications

• Mucopolysaccharidosis Type I

Where can I get more information?

• Your doctor or pharmacist can provide more information about laronidase.

See also: laronidase side effects (in more detail)